NCT03213899

Brief Summary

Previous studies have demonstrated the direct associations between malnutrition and hospital mortality as well as the length of stay in critically ill patients. However, the validity of these results may be limited by inappropriate diagnoses of malnutrition, small sample size, possible treatment bias, and sub-optimal statistical adjustment. This study aimed to further examine the aforementioned associations by addressing these limitations.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
503

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2015

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 31, 2016

Completed
8 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2017

Completed
4 days until next milestone

First Posted

Study publicly available on registry

July 11, 2017

Completed
Last Updated

July 11, 2017

Status Verified

July 1, 2017

Enrollment Period

1.3 years

First QC Date

July 7, 2017

Last Update Submit

July 9, 2017

Conditions

Critical IllnessMalnutrition

Keywords

Subjective Global AssessmentNutritional StatusHospital MortalityLength of StayMalnutrition

Outcome Measures

Primary Outcomes (2)

  • Hospital mortality

    Death during hospitalization

    Up to one year after admission to the ICU

  • ICU length of stay

    Duration of the first intensive care unit admission

    From the date of the first ICU admission to the date of the first change in ICU-status to HD-status or discharge to the general ward, for up to one year after admission to the ICU

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All patients ≥ 18 years old who had ≥ 24 hours length of stay in the ICU, and received a nutrition assessment (7-point SGA) from a dietitian within 48 hours of admission to the ICU.

You may qualify if:

  • ≥ 18 years old who had ≥ 24 hours length of stay in the ICU
  • received a nutrition assessment (7-point SGA) from a dietitian within 48 hours of admission to the ICU

You may not qualify if:

  • Nil

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Lew CCH, Yandell R, Fraser RJL, Chua AP, Chong MFF, Miller M. Association Between Malnutrition and Clinical Outcomes in the Intensive Care Unit: A Systematic Review [Formula: see text]. JPEN J Parenter Enteral Nutr. 2017 Jul;41(5):744-758. doi: 10.1177/0148607115625638. Epub 2016 Feb 2.

    PMID: 26838530BACKGROUND

MeSH Terms

Conditions

Critical IllnessMalnutrition

Condition Hierarchy (Ancestors)

Disease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsNutrition DisordersNutritional and Metabolic Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 7, 2017

First Posted

July 11, 2017

Study Start

August 1, 2015

Primary Completion

October 31, 2016

Study Completion

October 31, 2016

Last Updated

July 11, 2017

Record last verified: 2017-07

Data Sharing

IPD Sharing
Will not share